NCT07276035 Brain-Stomach Circuits in Chronic Nausea
| NCT ID | NCT07276035 |
| Status | Recruiting |
| Phase | — |
| Sponsor | David Levinthal |
| Condition | Chronic Nausea and Vomiting Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 219 participants |
| Start Date | 2026-01-28 |
| Primary Completion | 2030-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 219 participants in total. It began in 2026-01-28 with a primary completion date of 2030-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this study is to determine whether stimulation of the brain-stomach connection can influence stomach activity in healthy adults and in individuals suffering from chronic nausea. The main questions it aims to answer are: * What are the best brain sites to influence the stomach? * What are the effects of different stimulation patterns on stomach activity? * Does the stimulation affect the sensation of nausea in participants suffering from chronic nausea? Researchers will use a non-invasive method of brain stimulation called Transcranial Magnetic Stimulation (TMS) and will record stomach responses with skin electrodes on the abdomen. Participants will: * Visit the clinic at least once, and for up to 9 times more over the course of several months. * Receive TMS while sitting in a chair similar to a dentist's chair. * Drink water or consume a test meal during each study visit.
Eligibility Criteria
Inclusion Criteria: * Adults between ages 21-60 years old, with and without CNVS diagnosis per self-report. Exclusion Criteria: * body mass index (BMI) \> 30 * pregnancy or intention to become pregnant * past or present chemotherapy * diagnosis of gastric (stomach) cancer * any kind of gastric (stomach) surgery * current use of GLP-1 receptor agonists (e.g. Ozempic, Trulicity) * medications which significantly lower seizure thresholds (e.g. bupropion (Wellbutrin), fluoxetine (Prozac), or tramadol (Ultram)) * implantable devices, such as a pacemakers or nerve stimulators * history of head injury that required hospitalization, metal in the skull, or neurologic disease such as stroke, history of seizures or history of syncope (fainting or passing out) * neurodegenerative disease (Multiple Sclerosis, Parkinson's or Alzheimer's Disease) * ongoing psychosis or altered cognitive status status (e.g. hearing sounds or seeing visions that are not there, or feeling confused or suffering from memory lapses) * history of cardiovascular (i.e., heart attack), pulmonary (i.e., need for supplemental oxygen), or endocrine disease (e.g. diabetes) * current enrollment in another study using Transcranial Magnetic Stimulation (TMS) * current use of drugs such as amphetamines, methamphetamine, Ecstasy, Ketamine, Angel Dust/PCP, cocaine, or drinking 3 or more alcoholic drinks per day * For healthy subjects only: chronic history of gastrointestinal symptoms (e.g., nausea, indigestion, bloating, abdominal pain) * For CNVS subjects only: diagnosis of gastric motility disorder (e.g. gastroparesis/slow stomach emptying) or history of bowel obstruction (i.e., chronic partial small bowel obstruction)
Contact & Investigator
David J Levinthal, MD PhD
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT07276035 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 60 Years, studying Chronic Nausea and Vomiting Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07276035 currently recruiting?
Yes, NCT07276035 is actively recruiting participants. Contact the research team at phmk@pitt.edu for enrollment information.
Where is the NCT07276035 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT07276035 clinical trial?
NCT07276035 is sponsored by David Levinthal. The principal investigator is David J Levinthal, MD PhD at University of Pittsburgh. The trial plans to enroll 219 participants.